GW Pharmaceuticals plc

GW has developed an oral formulation of purified cannabidiol (CBD), initially approved as EPIDIOLEX^® in the U.S. by the U.S. Food and Drug Administration (FDA).  We initially launched EPIDIOLEX in the U.S. in November 2018 for the treatment for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients 2 years of age and older, two rare and severe early-onset, drug-resistant epilepsy syndromes. In July 2020, the FDA expanded the approval of Epidiolex, adding a new indication of seizures associated with Tuberous Sclerosis Complex or TSC in patients one year of age and older.  Along with this new indication, the age range was expanded to include patients one year of age and older who experience seizures associated with LGS or Dravet syndrome. TSC is a rare disease that causes benign tumors to grow in vital organs of the body and is a leading cause of genetic epilepsy. This is the first cannabis plant-derived medicine ever approved by the FDA and has been descheduled by the U.S. DEA. The medicine was launched in the US as a prescription medicine by our US operating subsidiary, Greenwich Biosciences Inc., on November 1, 2018. This product has received approval in the EU by the European Medicines Agency (EMA) under the tradename EPIDYOLEX^® for use as adjunctive therapy of seizures associated with LGS or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.* EPIDYOLEX is currently under review by the EMA for seizures associated with TSC. 

GW successfully developed the world’s first prescription medicine derived from the cannabis plant called Sativex^® (nabiximols) in Europe, a formulated cannabis extract that contains the principal cannabinoids delta-9-tetrahydrocannibinol (THC) and cannabidiol (CBD), as well as other minor cannabinoids and terpenes, which is now approved in numerous countries outside of the US for the treatment of spasticity due to multiple sclerosis. GW continues to research and develop nabiximols and is commencing separate clinical programs in the United States for spasticity due to multiple sclerosis and spinal cord injury and for Post-Traumatic Stress Disorder (PTSD). 

The company has a deep pipeline of additional clinical stage cannabinoid product candidates under development for both orphan and non-orphan indications with a particular focus on neurological conditions.

GW was co-founded in 1998 by Dr. Geoffrey Guy and Dr. Brian Whittle, two well-known entrepreneurs in the UK biotech sector. In setting up GW, Drs. Guy and Whittle worked closely with both the UK Home Office and the UK’s medicines regulatory authority on establishing necessary licenses and procedures so as to facilitate the progress of GW’s cannabinoid research program. A few months after its inception, Justin Gover joined the company as its first Chief Executive Officer.

In 1999, GW commenced its first clinical trials evaluating different cannabinoid formulations as potential therapeutics with an initial focus on the development of an oral mucosal spray of a complex botanical mixture comprised of two principal cannabinoid components, cannabidiol (CBD) and delta-9 tetrahydrocannabinol (THC), along with specific minor cannabinoids and non-cannabinoid plant components.

Working with leading cannabinoid scientists around the world, GW has continued to explore the potential of a range of novel cannabinoid molecules in a number of distinct therapeutic areas including epilepsy, autism, and schizophrenia.

GW’s focus is to bring novel, cannabinoid-based prescription medicines to patients in areas of serious unmet need and in which our medicines have the potential to make a real difference to their quality of life. Through the combination of rapid cost-effective product development that addresses these unmet needs, GW seeks to maximize the value of its product development opportunities and shareholder returns.

GW’s lead product is a liquid formulation of highly purified cannabidiol, or CBD. The FDA approved this product as EPIDIOLEX® (cannabidiol) in June 2018, initially for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients 2 years of age and older, two rare and particularly difficult to treat forms of epilepsy. The FDA has since approved EPIDIOLEX for the treatment of seizures associated with Tuberous Sclerosis Complex (TSC) in patients one year of age and older, and expanded the age range to include patients one year of age and older who experience seizures associated with LGS or Dravet syndrome. TSC is a rare disease that causes benign tumors to grow in vital organs of the body and is a leading cause of genetic epilepsy. The DEA has descheduled EPIDIOLEX. The product was launched in November 2018 and is now available by prescription only in the U.S.

This product also received approval in the EU by the European Medicines Agency (EMA) under the tradename EPIDYOLEX® for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.* GW is currently evaluating additional clinical development programs in other orphan seizure disorders and autism spectrum disorders. EPIDYOLEX is currently under review by the EMA for seizures associated with TSC.

GW is also developing nabiximols (US USAN name, known as Sativex® outside of the US) for the treatment of spasticity in patients with multiple sclerosis and spinal cord injury and for patients suffering with Post Traumatic Stress Disorder. 

GW’s strategy is to maintain a world leading position in the field of cannabinoid science and in the research, development and commercialization of cannabinoid molecules as novel prescription pharmaceutical therapeutic candidates. In seeking to implement this strategy, GW has developed an extensive international network of the most prominent scientists in the cannabinoid field and has also assembled a large in-house team with extensive experience in developing cannabinoids, medicines containing controlled substances, as well as plant-based prescription pharmaceutical product formulation. GW manufactures its prescription pharmaceutical products to meet the stringent cGMP requirements of the U.S. FDA and other global regulatory authorities. GW establishes controls over all facets of product development, manufacturing and commercial distribution.

The Values that Guide Our Path

Our mission inspires the work we do to transform the lives of our patients, and our values guide the way in which we do it.

• Patient driven – We never forget who we're striving for
• Passionate – We are here to change lives
• Innovative – We challenge ourselves to find new and better approaches
• Collaborative – We accomplish more through working together and valuing one another
• Accountable – We take responsibility and deliver on our commitments
• Integrity – We are fair, honest, and ethical
• Excellence – We pursue the highest standards for ourselves and for our industry 

Our Code of Conduct

We continually reinforce our values through our Code of Business Conduct & Ethics and I-CARE approach to conducting our global business in accordance with our Company Values.

At GW, we are committed to conducting our business in an ethical manner and in compliance with all applicable laws, rules and regulations. We created a principles-based approach, I-CARE, around the core elements of Integrity, Compliance, Accountability, Respect and Ethics.

We have developed a code of conduct that embodies our high ethical standards, and we are committed to operating our business, and conducting our relationships with patients, physicians and stockholders, accordingly.